Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

January 5, 2024 updated by: Sanofi

SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)

A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Chilly-Mazarin, France, 91380
        • Sanofi-Aventis, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months])

Description

Inclusion Criteria:

Following eligibility criteria are defined to select relevant studies from the literature

  • Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months]))
  • Participants have received either Dronedarone or Sotalol
  • controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies

Exclusion Criteria:

Exclusion criteria for potential participants are:

  • Children/adolescents
  • Permanent atrial fibrillation (AFib)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Cardiovascular (CV) hospitalization
Time Frame: As reported in studies included in the systematic review up to 10 years
CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke
As reported in studies included in the systematic review up to 10 years
Number of participants with ventricular proarrhythmia
Time Frame: As reported in studies included in the systematic review up to 10 years
As reported in studies included in the systematic review up to 10 years
Number of all-cause mortality events
Time Frame: As reported in studies included in the systematic review up to 10 years
As reported in studies included in the systematic review up to 10 years
Number of cardiovascular mortality events
Time Frame: As reported in studies included in the systematic review up to 10 years
includes arrhythmia-related mortality
As reported in studies included in the systematic review up to 10 years
Number of participants with atrial fibrillation (AFib) recurrence
Time Frame: As reported in studies included in the systematic review up to 10 years
As reported in studies included in the systematic review up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with myocardial infarction
Time Frame: As reported in studies included in the systematic review up to 10 years
As reported in studies included in the systematic review up to 10 years
Number of participants with stroke
Time Frame: As reported in studies included in the systematic review up to 10 years
As reported in studies included in the systematic review up to 10 years
Number of participants with heart failure hospitalization
Time Frame: As reported in studies included in the systematic review up to 10 years
As reported in studies included in the systematic review up to 10 years
Number of participants with AFib hospitalization
Time Frame: As reported in studies included in the systematic review up to 10 years
As reported in studies included in the systematic review up to 10 years
Number of participants with conduction disorders
Time Frame: As reported in studies included in the systematic review up to 10 years
Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants
As reported in studies included in the systematic review up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences and Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSA0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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